Body-space drainage-tube debris removal

ABSTRACT

In accordance with embodiments of the present invention, a debris removal system is provided for a body-space drainage system having one or more body tubes with a body tube lumen disposed therein. The debris-removal system comprises an elongated cleaning member and a cleaning head adapted to be advanced distally at least a portion of a length of the body tube lumen to dislodge debris therein. A collapsible sheath can be used to maintain a sterile field in the body tube lumen while the cleaning member is being used by enclosing at least a portion of the cleaning member that is not contained within the body tube lumen, and permitting external digital manipulation of the cleaning member through the sheath to advance and/or retract the cleaning member, and cleaning head, in the body tube lumen.

RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.10/555,130 now U.S. Pat. No. 7,854,728 filed Oct. 31, 2005 and claimspriority there from, which application is a National stage entry of PCTApplication No. PCT/US04/13728 filed May 3, 2004 and claims prioritythere from, and claims priority from U.S. Provisional Application Ser.No. 60/467,391, filed May 2, 2003, U.S. Provisional Application Ser. No.60/555,550 filed Mar. 22, 2004 and the contents of which are herebyincorporated by reference as if recited in full herein for all purposes.

FIELD OF THE INVENTION

The present invention relates to surgical instruments, and moreparticularly, to body-space drainage systems.

BACKGROUND OF THE INVENTION

Millions of patients have surgical procedures or other conditions thatrequire the placement of a tube or catheter in a body space for drainageof fluids and gases. For example, many chest disorders due to cancer,infection, heart disease, trauma, and other maladies require thetemporary placement of a body-space drainage tube (also referred to as abody tube) into one or more spaces within the chest.

Coronary and heart-valve disease patients require temporary pleural andpericardial drainage in the post-operative period. Patients with lungdisorders require temporary drainage of the pleural space due to pleuraleffusion. Patients suffering from chest trauma require various pleuralinterventions to treat collapsed and injured lungs. Patients with AIDSoften have respiratory manifestations, many of which lead to effusionsor pneumothoraces that require drainage from the chest.

A chest tube is a type of body-space drainage tube placed in the chestin a process known as tube thoracostomy. The chest tube is part of adrainage system that also comprises a drainage canister used to collectthe drained fluids. In some cases, a vacuum is drawn out of the drainagecanister to help expedite the drawing of fluids, gases, or both from thechest. While design advances have been made in the drainage canister,very little has changed with the chest tube itself.

FIG. 1 is an illustration of a common body-space drainage-tube system 2.The drainage-tube system 2 comprises one or more body tubes 10,corresponding coupler 12, a canister tube 14, a drainage canister 16,and a vacuum source 18. A body tube 10 is a long, semi-stiff, clearplastic tube having a body-tube distal end 11 that is inserted into thechest or other body space (or body cavity) and a body-tube proximal end13 that extends outside of the body for coupling with the canister tube14 via the coupler 12. The body tube 10 provides a fluid path from thebody space to the canister tube 14, so as to drain fluid, gas, or bothfrom the body space. In a system known as a closed-suction drainagesystem, additional components, such as a vacuum source 18 creates lowpressure in the canister to draw the fluids, gases, or both out of thebody space and into the drainage canister 16.

Body tubes 10 are used to treat may medical conditions. For example, ifa lung is compressed due to a collection of fluid, the body-tube distalend 11 of a body tube 10 is inserted into the space between the pleuraor within the mediastinum. This placement of a body tube 10 inside thechest drains the collection of fluid and allows the lung to re-expand.

Body tubes 10, especially the larger variety, are inserted mostly bysurgeons, but also by pulmonologists, radiologists, critical-carephysicians, primary-care doctors, and emergency personnel. Largediameter, large lumen body tubes drain thick pleural fluids moreeffectively than smaller tubes, in part because a bigger lumen cantolerate more debris without clogging than a smaller lumen.Large-diameter body tubes are not always well tolerated by the patientdue to pain, however, and the inability to direct the insertion can leadto incorrect placement. Even the larger tubes can become clogged withblood clots and fibrinous material.

Bleeding often occurs after heart surgery or trauma. When this occurs,the blood can clot in the tube inside the patient, impairing thefunction of the body tube. Bleeding and clotting in the tube in thiscircumstance can be life threatening for two reasons. First, clinicianscarefully monitor the amount of blood that comes out of the tube as ameasure of the seriousness of the amount of bleeding. If blood pools inthe chest, for example, then the measurement omits the pooled blood,because it is not draining through the body tube. The patientconsequently can lose a large volume of blood without awareness of thehealth care practitioner and thus, without treatment for the blood loss.This blood loss can have severe hemodynamic consequences, includingdeath. Second, if blood pools in the pericardial space, it can compressthe structures of the heart, impairing the return of blood to the heart,and thus the ability of the ventricle to fill and empty. This condition,called pericardial tamponade, likewise can be fatal.

When clinicians caring for patients in the perioperative periodfollowing surgery and trauma notice a clot forming in the body tube,they often undertake various measures to try to remove the blood clot.One method is to simply tap the body tube to try to break up the clot.Another method is to “milk the tube,” which involves using fingers (or arudimentary device made from a pair of pliers with added roller heads)to compress the body tube over the clot to break up the clot. Thismethod has the effect of pulling some of the clot towards the canistertube 14 that goes to the drainage canister 16. In another method, called“fan folding,” the clinician bends the body tube in various ways in anattempt to break up any long clots and to facilitate flow to thecanister. Any manipulation of a body tube in this fashion can be quitepainful to the patient.

Another technique is known as “stripping.” In this technique, theclinician uses two or more lubricated fingers to compress, or pinch, thebody tube near its entry point into the body. The clinician then slidesthe pinching fingers along the body tube, towards the drainage canister16. Repeating this motion tends to move clots and debris toward thecanister. This technique is only marginally successful. Further, thetechnique is known to generate short bursts of strong negative pressureat the ends of the body tube. This negative pressure causes a suctioneffect that can be dangerous because it can yield pressures of up to−300 cm of water adjacent to suture lines on, for example, coronaryanastomosis. The resulting forces can damage the work that was donesurgically during the operation. This damage is potentially lifethreatening.

None of these non-invasive techniques for removing debris from the bodytube are uniformly successful, and all of them consume valuable time inthe postoperative period. More-drastic methods also exist. These methodsare more effective at cleaning—but more risky to the patient. In onescenario, a sterile field is made up, the body tube is disconnected atthe coupler 12, and a suction catheter is run up the body tube to clearthe debris.

This open-suction technique is generally effective, but it is highlyundesirable for several reasons. First, it violates the sterile internalenvironment of the body-space drainage tube system, potentiallyintroducing bacteria inside the patient's body. Second, for body tubesplaced in the chest, it breaks the seal between the body tube and thecanister, causing a loss of the physiologic negative pressure inside thechest. As a result, the lungs can collapse (pneumothorax) whilebody-tube cleaning is being carried out. Finally, it is time-consumingfor the nurses or doctors to perform the procedure.

Because of the fear of clogging, clinicians often place more than onebody tube, creating auxiliary drainage capacity but worsening pain andpotential complications. After the patient makes it through the initialstage of recovery, when clogging can be life threatening, the patient isleft with several large-diameter body tubes passing through skin,muscle, and other tissues to reach the body space to be drained ortreated.

Chest tubes, for example, typically pass through the ribs of the chestwall, where the tubes lie next to the lung and along the pleura. Thisplacement means that any movement, such as cough, is quite painful. Bodytubes are also notorious sites for infection, and multiple tubesincrease this risk. When the tubes are left in place for more than a dayor so, clogging becomes an issue, as fibrin and other material form inthe end of the tube, impairing its function. In support of theseconcepts, body tubes almost always have a significant clot in the distalend when removed. Any body tube left in place for several days willeventually fail (called a “dead tube”) due to clogging. To avoid thedanger and hassle of dealing with clogged tubes, surgeons chooselarge-lumen body tubes and place multiple body tubes, especially afterheart surgery, lung surgery, or trauma.

Solving the issue of clogging will allow body tubes to function withbetter safety and less nursing care. Devices and methods are needed inthe art that effectively eliminates clogging and clotting in body tubes,reducing the need for painful and ineffective manipulations of thetubes, and thus reducing the trauma around the tube that can contributeto bleeding, tissue injury, and infection. A benefit will be thatsmaller body tubes, and perhaps fewer body tubes, can be used, since thereason to use the larger-diameter tubes is to facilitate evacuation ofdebris and clots that tend to more easily obstruct the smaller tubes.The net result will be reduced pain, faster recovery, and less cost.

Because larger body tubes require more specialty expertise to place,they are usually placed only by surgeons, with pulmonologists or othersplacing smaller, less effective body tubes. The availability ofeffective body tubes at smaller diameters will increase the number ofclinicians who can insert and manage those tubes.

SUMMARY OF THE INVENTION

Embodiments of the present invention increase the efficiency ofbody-space drainage-tube systems by incorporating a debris-removalsystem to keep the body tube clear of clots and other debris.Embodiments of the present invention provide a body-tube cleaning andclearing apparatus that can be efficiently, easily, and routinely usedto maintain the flow within the body tube free from the accumulation ofblood, pus, foam, secretions, and other debris. In embodiments inaccordance with the present invention, the apparatus are used forremoving debris from body tubes such as, but not limited to, chest tubesand catheters. The embodiments eliminate the questionable practices ofmilking, fan folding, stripping, and open suction, easing patient painand reducing the risk of infection.

Various embodiments of the present invention provide a sterile sheatharound a suction/aspiration catheter with a balloon at the tip that canbe slid in and out of a body tube to clear it of clot, fluid, anddebris. In one embodiment of the present invention, the body-tubecleaning-apparatus includes an elongate tubular catheter having adiameter smaller than the interior diameter of the body tube. Further,the elongate tubular catheter includes a distal end that is structuredto be introduced and extended into the lumen of the body tube. The tipof the catheter is blunt and rounded to avoid direct injury to theinternal thoracic organs if it should exit the body-tube distal end. Thesides at the body tube distal end have holes for suction. Defined withinthe elongate tubular member, and extending from generally a proximal endto a distal end is a lumen. The lumen provides a fluid path thatterminates in an outlet port defined in the elongate tubular catheter.The elongate tubular catheter is encased in a sterile envelope thatallows it to be slid in and out of the chest tube without exposing it tothe outside, un-sterile, environment.

In accordance with the present invention, a debris-removal system isprovided for a body-space drainage system having one or more body tubes,each body tube having a body-tube distal end and a body-tube proximalend with a body tube lumen disposed therein The debris-removal systemcomprises a cleaning member, a collapsible sheath, and a coupler.Wherein the cleaning member is an elongated member having a cleaningmember distal end and a cleaning member proximal end, the cleaningmember distal end adapted to enter the body tube lumen at or near thebody-tube proximal end and adapted to be advanced distally at least aportion of a length of the body tube lumen. The collapsible sheath isadapted to contain at least a portion of the cleaning member that is notcontained within the body tube lumen. The collapsible sheath is flexibleso as to allow external digital manipulation of the cleaning memberproximal end within of the collapsible sheath.

In accordance with another embodiment, the debris-removal systemprovides wherein the collapsible sheath is adapted for permittingadvancement, retraction and manipulation of the cleaning member withinthe body tube lumen from outside of the collapsible sheath. Inaccordance with another embodiment, the debris-removal system provideswherein the collapsible sheath is adapted to contain a fully retractedcleaning member. In accordance with another embodiment, thedebris-removal system provides wherein the collapsible sheath adapted tocouple at or near the proximal end of the body tube in fluid tight andsterile seal engagement with the body tube lumen.

In accordance with another embodiment, the debris-removal systemprovides wherein the cleaning member is adapted to be advanced andretracted within the body tube lumen without breaking the sterile sealengagement.

In accordance with another embodiment, the debris-removal systemprovides wherein the coupler comprises a body tube port adapted tocouple with the body tube, a canister tube port adapted to couple withthe canister tube, and a collapsible sheath port adapted to couple thecollapsible sheath, wherein the coupler-defines a passage incommunication with the body tube port, the canister tube port and thecollapsible sheath port, the passage adapted to receive the cleaningmember. In accordance with another embodiment, the debris-removal systemprovides wherein the coupler is adapted to provide a removable couplingbetween the debris-removal system and the drainage system. In accordancewith another embodiment, the debris-removal system provides wherein thecleaning member is a flexible filament. In accordance with anotherembodiment, the debris-removal system provides wherein the flexiblefilament is selected from a list consisting of semi-rigid wire, plasticrod, and tubing. In accordance with another embodiment, thedebris-removal system provides wherein the flexible filament is adaptedto mechanically clean the body tube lumen using mechanical dislodgmentof the debris, the flexible filament being sufficiently flexible totraverse the curvature of the body tube lumen and sufficiently rigid soas to advance through the body tube lumen by manipulation from about thecleaning member proximal end and to dislodge and/or break up foreignmatter within the body tube lumen as it makes contact with the foreignmatter.

In accordance with another embodiment, the debris-removal systemprovides wherein the cleaning member distal end comprises a cleaningmember distal tip adapted to provide a rough abrasive surface so as toassist in dislodging foreign matter within the body tube lumen. Inaccordance with another embodiment, the debris-removal system provideswherein the debris-removal system further comprises a filamentmanipulation device removably coupled with the cleaning member proximalend and adapted to impart vibratory excitation thereto.

In accordance with another embodiment, the debris-removal systemprovides wherein the collapsible sheath comprises a collapsible sheathproximal end adapted to couple with the cleaning member proximal end,the debris-removal system further comprising a filament manipulationdevice removably coupled with the collapsible sheath proximal end. Inaccordance with another embodiment, the debris-removal system provideswherein the filament manipulation device comprises an ultrasonictransducer that couples sonic energy to the cleaning member. Inaccordance with another embodiment, the debris-removal system provideswherein the debris-removal system further comprises a filamentmanipulation device removably coupled with the cleaning member proximalend, the filament manipulation device adapted to couple with thecollapsible sheath proximal end and impart a circulatory motion to thecleaning member.

In accordance with another embodiment, the debris-removal systemprovides wherein the collapsible sheath proximal end comprises arotatable coupling adapted to couple the cleaning member with themanipulation device, the rotatable coupling adapted to provide a fluidand sterile seal while allowing the manipulation member to rotate thecleaning member.

In accordance with another embodiment, the debris-removal systemprovides wherein the debris-removal system further comprises a tubularfilament comprising an elongated tubular filament having a tubularfilament proximal end, tubular filament distal end, and a filament lumenthere through. The filament lumen defining a flow path to and/or fromthe tubular filament distal end, the tubular filament being sufficientlyflexible to traverse curvature of the body tube lumen, but issufficiently rigid so as to advance through the body tube lumen bypushing from the proximal end and to dislodge and/or break up foreignmatter within the body tube lumen.

In accordance with another embodiment, the debris-removal systemprovides wherein the filament lumen is adapted to provide a suction orvacuum path for the collection and removal of the dislodged debris, thetubular filament distal end adapted for coupling with a vacuum sourceand adapted to extract foreign material.

In accordance with another embodiment, the debris-removal systemprovides wherein the debris-removal system is adapted to be coupled to achest tube in a closed-suction tube system to drain blood and fluid andair from the chest.

In accordance with another embodiment, the debris-removal systemprovides wherein the tubular filament distal end comprises an angulartip.

In accordance with another embodiment, the debris-removal systemprovides wherein the debris-removal system further comprises a fluidsource, the filament lumen adapted for expelling fluid from the tubularfilament distal end.

In accordance with another embodiment, the debris-removal systemprovides wherein the fluid source is adapted to supply fluid expelled atthe tubular filament distal end at a predetermined pressure tomechanically dislodge and/or break up the foreign material.

In accordance with another embodiment, the debris-removal systemprovides wherein the fluid source is adapted to supply fluid with sonicenergy.

In accordance with another embodiment, the debris-removal systemprovides wherein the fluid source is adapted to provide fluid comprisinga solution adapted to assist in the dislodgment, dissolution and/orbreakup of the foreign matter.

In accordance with another embodiment, the debris-removal systemprovides wherein the fluid is a therapeutic agent selected from a listcomprising antibiotic agents and anti-neoplastic agents.

In accordance with another embodiment, the debris-removal systemprovides wherein the cleaning member is a tubular filament comprising atubular filament distal end having an expandable portion coupled to afilament lumen, the expandable portion adapted to have a relaxed statein which the distal end has a minimal profile and an expanded statewherein the distal end has an enlarged profile, the expandabledebris-removal system further comprises an inflatable fluid deliverysystem adapted to communicate inflation fluid to the expandable portion,the expandable portion adapted to expand by the advancement of inflationfluid from an fluid delivery system, through the lumen to the expandableportion, the inflation fluid controlled at the tubular member proximalend. The expandable portion of the distal tip is adapted to expand underfluid pressure and recoil back to substantially the original positionupon withdrawal of the fluid pressure.

In accordance with another embodiment, the debris-removal systemprovides wherein the expanded portion is adapted to fully occlude thebody tube lumen when in the expanded state.

In accordance with another embodiment, the debris-removal systemprovides wherein the inflatable fluid delivery system comprises areservoir adapted to be coupled to the lumen at the proximal end of thecleaning member.

In accordance with another embodiment, the debris-removal systemprovides, wherein the reservoir comprises an elastic bulb, balloon orfluid-filled syringe coupled to the cleaning member through a coupling.

In accordance with another embodiment, the debris-removal systemprovides wherein the fluid reservoir is provided within the collapsiblesheath.

In accordance with another embodiment, the debris-removal systemprovides wherein the expandable portion comprises an arrowhead orumbrella-shaped profile.

In accordance with another embodiment, the debris-removal systemprovides wherein the expandable portion is along a portion of the lengthof the distal end, in fluid communication with the tubular filamentlumen and adapted to expand upon presented with fluid pressure, to alarger diameter than a relaxed state.

In accordance with another embodiment, the debris-removal systemprovides wherein the expandable portion is a plurality of expandableportion spaced a predetermined distance apart along the length of thecleaning member.

In accordance with another embodiment, the debris-removal systemprovides wherein the distal end further comprises an elastic cordadapted to couple with the body tube distal end so as to provide arestoring force to reposition the cleaning member adjacent the body tubedistal end.

In accordance with another embodiment, the debris-removal systemprovides the distal end further comprising a cross-bar support adaptedto couple the cleaning member to the body tube distal end.

In accordance with another embodiment, the debris-removal systemprovides wherein the expandable portion comprises an umbrella-likeexpandable portion comprising of a plurality of struts and web, theumbrella-like expandable portion adapted to collapse to a narrowprofile, and expand to substantially occlude the body tube lumen.

In accordance with another embodiment, the debris-removal systemprovides wherein distal end further comprises an elastic cord adapted tocouple with the body tube distal end so as to provide a restoring forceto reposition the cleaning member adjacent the body tube distal end.

In accordance with another embodiment, the debris-removal systemprovides wherein the expandable portion comprises a plurality ofumbrella-like expandable portions comprising of a plurality of strutsand webs, at least two of the plurality of expandable portions coupledto adjacent expandable portions with an elastic cord.

Various embodiments of the present invention, singularly or incombination, are to provide a body-space drainage-tube cleaningapparatus.

DRAWINGS

FIG. 1 is a side view of a common body-space drainage-tube system;

FIG. 2 is a front view of a debris-removal system coupled with abody-space drainage-tube system in accordance with an embodiment of thepresent invention;

FIG. 3 is an exploded view of a debris-removal system in accordance withan embodiment of the present invention;

FIGS. 4 and 5 are partial side views of a flexible filamentdebris-removal system in accordance with an embodiment of the presentinvention;

FIG. 6A is a side view of a cleaning member distal end comprising acleaning head in accordance with an embodiment of the present invention;

FIG. 6B is a side view of a cleaning member distal end comprisingcleaning member distal tip in accordance with embodiments of the presentinvention;

FIG. 7 is a side view of a debris-removal system further comprising afilament manipulation device in accordance with embodiments of thepresent invention;

FIG. 8 is a side view of a debris-removal system further comprisinganother embodiment of a filament manipulation device in accordance withembodiments of the present invention;

FIG. 9 is a partial side view of a tubular filament debris-removalsystem, wherein the cleaning member is a tubular filament, in accordancewith embodiments of the present invention;

FIG. 10 is a partial side view of a tubular filament distal endcomprising an angular tip, in accordance with an embodiment of thepresent invention;

FIG. 11 is a partial side view of a tubular filament debris-removalsystem adapted for expelling fluid from the tubular filament distal end,in accordance with an embodiment of the present invention;

FIG. 12A is a partial side view of an expandable debris-removal system,wherein the cleaning member is a tubular filament comprising a tubularfilament distal end having an expandable portion, in accordance with anembodiment of the present invention;

FIG. 12B is a partial side view of an expandable debris-removal system,wherein the cleaning member is a tubular filament comprising a tubularfilament distal end having an expandable portion, in accordance with anembodiment of the present invention;

FIG. 13 is a side view of an arrowhead expandable distal tip having anarrowhead-shaped profile, in accordance with an embodiment of thepresent invention;

FIG. 14 is a side view of an expanding wall cleaning member comprisingan expandable portion along a portion of the length of the distal end inaccordance with an embodiment of the present invention;

FIG. 15A is a side view of the distal end comprising an expandableportion not integral with the tubular filament, in accordance with anembodiment of the present invention;

FIG. 15B is a side view of the distal end comprising a plurality ofexpandable portions not integral with the tubular filament, inaccordance with an embodiment of the present invention;

FIG. 16A is a side view of a distal end comprising an expandableportion, further comprising an elastic cord in accordance with anembodiment of the present invention;

FIG. 16B is a side view of a distal end comprising an expandableportion, further comprising an elastic cord in accordance with anembodiment of the present invention;

FIG. 17 is a side view of a distal end of an umbrella cleaning membercomprising an umbrella-like expandable portion in accordance with anembodiment of the present invention;

FIG. 18 is a side view of a distal end of a cleaning member of FIG. 17;

FIG. 19 is a side view of a distal end of a cleaning member of FIG. 17;

FIG. 20 is a side view of a distal end of a cleaning member comprising aplurality of umbrella-like expandable portions, in accordance with anembodiment of the present invention; and

FIG. 21 is a side view of a distal end of a body tube that is bifurcatedinto a plurality of body tube distal ends in accordance with anembodiment of the present invention.

FIG. 22 is a side view of a distal end of a body tube that is bifurcatedinto a plurality of body tube distal ends, wherein each body tube distalend is associated with a cleaning member, in accordance with anembodiment of the present invention.

DESCRIPTION

Referring again to FIG. 1, a common body-space drainage system 2comprises one or more body tubes 10, corresponding coupler 12, acanister tube 14, a drainage canister 16, and a vacuum source 18. A bodytube 10 is a long, semi-stiff, clear plastic tube having a body-tubedistal end 11 and a body-tube proximal end 13 with a body tube lumen 15disposed therein The body-tube distal end 11 is adapted to be insertedinto the chest or other body space (or body cavity) and the body-tubeproximal end 13 is adapted to extend outside of the body for couplingwith the canister tube 14. Various embodiments in accordance with thepresent invention are used to clear the body tube lumen 15 of foreignmaterial, such as, but not limited to, blood clot, that can impair thefunction of the body tube 10. Various embodiments of the presentinvention are also used to irrigate the body tube 10.

FIG. 2 is a perspective view of a debris-removal system 20 in accordancewith an embodiment of the present invention. The debris-removal system20 comprises a cleaning member 24, a collapsible sheath 22, and acoupler 23. The debris-removal system 20 is shown as assembled onto abody-space drainage system 2.

The cleaning member 24 is an elongated member comprises a cleaningmember distal end 26 and a cleaning member proximal end 28. The cleaningmember distal end 26 is adapted to enter the body tube lumen 15 at ornear the body-tube proximal end 13 and be advanced distally at least aportion of the length of the body tube lumen 15. The collapsible sheath22 is adapted to contain at least a portion of the cleaning member 24that is not contained within the body tube lumen 15. The collapsiblesheath 22 is adapted to be flexible so as to allow external digitalmanipulation of the cleaning member proximal end 28 within of thecollapsible sheath 22. For example, the collapsible sheath 22 allows forgrasping a portion of the cleaning member 24 within the collapsiblesheath 22 for advancing, retracting and manipulating the cleaning member24 within the body tube lumen 15.

The collapsible sheath 22 comprises a suitable material for theparticular purpose. In embodiments in accordance with the presentinvention, the collapsible sheath 22 comprises a flexible filmcomprising synthetic resinous material, such as, but not limited to,medical grade polyethylene film. The collapsible sheath 22 is manuallycollapsed, such as between the thumb and index finger of thepractitioner, and the like, in order to manipulate the cleaning member24 contained therein. The collapsible sheath 22 is adapted to retain andmaintain a sterile environment, and, were applicable, the vacuum, of thebody-space drainage system 2.

In embodiments in accordance with the present invention, the collapsiblesheath 22 is adapted to contain a fully retracted cleaning member 24 soas to provide an unobstructed flow path through the body tube lumen 15to the canister tube 14.

The collapsible sheath 22 is adapted to couple at or near the proximalend 13 of the body tube 10 so as to provide a fluid tight and sterileseal with the body tube lumen 15. The cleaning member 24 can thereforebe advanced and retracted within the body tube lumen 15 without the needto break the sterile seal or to interrupt the vacuum of a closed vacuumsystem.

FIG. 3 is an exploded view of the debris-removal system 20, inaccordance with an embodiment of the present invention. The coupler 23comprises a body tube port 25, a canister tube port 28, and thecollapsible sheath port 29. The body tube port 25 and the canister tubeport 28 are adapted to couple with the body tube 10 and canister tube14, respectively. The collapsible sheath port 29 is adapted to couplethe collapsible sheath 22. The coupler 23 is adapted to provide a fluidpath between the body tube 10 and the canister tube 14, and a path toinsert the cleaning member 24.

In an embodiment in accordance with the present invention, the coupler23 is adapted to provide a removable coupling between the collapsiblesheath 22 and the drainage system 2. The collapsible sheath 22 iscoupled to the coupler 23 at the coupling end 25 of the collapsiblesheath 22. The collapsible sheath 22 permits the operator to manipulatethe cleaning member 24 and insert the cleaning member distal end 26 intothe body tube 10 via the collapsible sheath port 29 of the coupler 23while maintaining sterility and vacuum. The proximal end 28 of thecleaning member 24 remains outside the coupler 23 so that the operatorcan manipulate the cleaning member 24 with isolation maintained by thecollapsible sheath 22.

Embodiments of the present invention provide a coupler 23 to provide useof the debris-removal system 20 without disconnection of the canistertube 14. It is understood that other embodiments are anticipatedproviding the debris-removal system 20 to couple with a straight coupler12, as shown in FIG. 1, but requiring the disconnection of the canistertube 14.

Various embodiments of the cleaning member 24 are anticipated, some ofwhich are presented below.

FIGS. 4 and 5 are partial side views of a flexible filamentdebris-removal system 30, wherein the cleaning member 24 is a flexiblefilament 24 a, in accordance with an embodiment of the presentinvention. The flexible filament 24 a is fabricated from materialsuitable for the particular purpose, including, but not limited to,polymers, such as, but not limited to polyvinyl chloride, in the form ofsuch as, but not limited to, wire, plastic rod, and tubular members.

The flexible filament is adapted to mechanically clean the body tubelumen 15 using mechanical dislodgment of the foreign material 19. Theflexible filament 24 a is sufficiently flexible to traverse thecurvature of the body tube lumen 15, but is sufficiently rigid so as toprevent buckling when advanced through the body tube lumen 15 by pushingfrom about the cleaning member proximal end 28 and to dislodge and/orbreak up foreign material 19 within the body tube lumen 15 as it makescontact with the foreign matter. The foreign material 19 is dislodgedfrom the body tube lumen 15 and carried to the canister (not shown) viathe vacuum system (not shown).

FIG. 6A is a side view of a cleaning member distal end 26 comprising acleaning head 31 that is at an oblique angle relative to the cleaningmember, in accordance with an embodiment of the present invention. Thecleaning head 31 is adapted to provide additional surface area and/ormeans for dislodging and/or break up of foreign material 19 within thebody tube lumen 15.

FIG. 6B is a side view of a cleaning member 24 a in accordance with anembodiment of the invention. The cleaning member 24 a comprises acleaning member distal end 26 comprising a cleaning member distal tip 46adapted to provide an enhanced surface, such as, but not limited to, anabrasive or sharp surface, so as to assist in dislodging foreignmaterial 19 within the body tube lumen 15.

FIG. 7 is a side view of a debris-removal system 20 further comprising afilament manipulation device 52, the coupler not shown, in accordancewith an embodiment of the present invention. The filament manipulationdevice 52 is adapted to couple with the cleaning member proximal end 28and impart vibratory excitation thereto.

The collapsible sheath 22 comprises a collapsible sheath proximal end 33that is coupled with the cleaning member proximal end 28. The filamentmanipulation device 52 is adapted to couple with the collapsible sheathproximal end 33 and therefore couple with the cleaning member proximalend 28. In one embodiment, the filament manipulation device 52 imparts avibratory motion to the cleaning member 24 which provides relativemotion to the cleaning member distal tip 26. This relative motion of thecleaning member distal tip 26 assists in the dislodgment and/or breakupof the foreign material 19 when placed in contact therewith.

In another embodiment in accordance with the present invention, thefilament manipulation device 53 comprises an ultrasonic transducer thatcouples sonic energy to, and therefore vibratory motion, the cleaningmember 24. A vibratory motion is adapted to induce sonic motion to thecleaning member distal tip 26 as well as any surrounding fluid, furtherassisting in the breakup and/or dislodgment of the foreign material 19.

FIG. 8 is a side view of a debris-removal system 20 further comprisinganother embodiment of a filament manipulation device 53, in accordancewith the present invention. The collapsible sheath 22 comprises acollapsible sheath proximal end 33 that is coupled with the cleaningmember proximal end 28. The filament manipulation device 53 is adaptedto couple with the collapsible sheath proximal end 33 and thereforecouple with the cleaning member proximal end 28. In an embodiment, thefilament manipulation device 53 imparts a rotary motion to the cleaningmember which provides rotary motion, or whipping motion, to the cleaningmember distal tip 26. This rotary motion of the cleaning member distaltip 26 assists in the dislodgment and/or breakup of the foreign material19.

In an embodiment in accordance with the present invention, thecollapsible sheath proximal end 33 comprises a rotatable coupling 35.The rotatable coupling 35 is adapted to couple the cleaning memberproximal end 33 with the manipulation device 53. The rotatable coupling35 is adapted to provide a fluid and sterile seal while allowing themanipulation device 53 to rotate the cleaning member 24 a.

It is anticipated that the manipulation device 53 can be adapted toprovide various motions to the cleaning member 24 a to assist in thebreakup and/or removal of the foreign material 19. These motionsinclude, but are not limited to, vibration, rotation, oscillatoryrotation, and combinations there of.

FIG. 9 is a partial side view of a tubular filament debris-removalsystem 40, coupler not shown, wherein the cleaning member 24 is atubular filament 24 b, in accordance with an embodiment of the presentinvention. The tubular filament 24 b comprises a tubular filamentproximal end 38, tubular filament distal end 36, and a filament lumen 37there through. As with the filament member 24 a described above, thetubular filament 24 b is adapted to mechanically clean the body tubelumen 15 by mechanical breakup and/or dislodgment of the foreignmaterial 19.

In another embodiment in accordance with the present invention, thefilament lumen 37 provides a flow path to and/or from the tubularfilament distal end 36 and the tubular filament proximal end 38. Thetubular filament 24 b is sufficiently flexible to traverse curvature ofthe body tube lumen 15, but is sufficiently rigid so as to advancethrough the body tube lumen 15 without buckling by pushing from thetubular filament proximal end 38 and to dislodge and/or break up foreignmaterial 19 within the body tube lumen 15.

In one embodiment as shown in FIG. 9, the filament lumen 37 is adaptedto provide a suction or vacuum path for the collection and removal ofthe dislodged foreign material 19. The tubular filament proximal end 38is coupled with a vacuum source 39 adapted to extract the foreignmaterial 19. By way of example, wherein the debris-removal system 40 iscoupled to a chest tube in a closed-suction tube system to drain bloodand fluid and air from the chest, this embodiment of the presentinvention provides a second closed-suction tube system to clear the bodytube lumen 15, in essence, providing a double closed-suction system.

A tubular filament 24 b suitable for the particular purpose includes,but is not limited to, a suction catheter adapted to vacuum-removeloosened foreign material 19. In accordance with an embodiment of thepresent invention, a debris-removal system comprises a closed trachealsuction system used for the drainage of endotracheal tubes and a coupler23, suitable to provide access to the closed tracheal suction system andthe endotracheal tubes.

FIG. 10 is a partial side view of a tubular filament 24 b including atubular filament distal end 36 a comprising an obliquely angular tip 34,in accordance with an embodiment of the present invention. The angulartip 34 provides an aggressive structure to assist in the dislodgment ofthe foreign material.

It is anticipated that the tubular filament embodiments can be augmentedwith embodiments of the manipulation device 52 as presented previously.

FIG. 11 is a partial side view of the tubular filament debris-removalsystem 42, wherein the cleaning member 24 is a tubular filament 24 bwith a filament lumen 37 adapted for expelling fluid from the tubularfilament distal end 36, in accordance with the present invention. Atubular filament 24 b suitable for the particular purpose includes, butis not limited to, a catheter with a distal irrigation port adapted toexpel fluid.

In one embodiment in accordance with the present invention, the fluid isexpelled from the tubular filament distal end 36 at a predeterminedpressure so as to assist in the dislodgment and/or break up of theforeign material 19. A fluid jet 42 is produced so as to provide anaggressive cleaning action. The fluid jet 42 is adapted to mechanicallydislodge and/or break up the foreign material. The fluid jet 42 can becontinuous or pulsed.

In another embodiment in accordance with the present invention, thefluid jet 42 is provided with sonic energy to provide vibratory actionto the fluid to further assist in the cleaning action.

In an embodiment in accordance with the present invention, a fluidsupply system 43 is coupled to the collapsible sheath proximal end 33 ofthe collapsible sheath 22 in fluid communication with the tubularfilament distal end 38.

In another embodiment in accordance with the present invention, thefluid expelled from the tubular filament distal end 38 is a solutionprovided to assist in the dislodgment, dissolution and/or breakup of theforeign matter. Fluids suitable for the particular purpose include, butare not limited to, anti-thrombolytic agents, Alkalol™, among others.

In another embodiment in accordance with the present invention, thefluid expelled from the tubular filament distal end 38 is a therapeuticagent added to provide integrity of the drainage system 2. Fluidssuitable for the particular purpose include, but are not limited to,antibiotic agents and anti-neoplastic agents.

Once dislodged and/or broken up, the foreign material flows through thebody tube lumen 15 to the canister tube 14 and drainage canister 16, asshown in FIG. 2.

In other embodiments in accordance with the present invention, thefilament lumen 37 of the tubular filament 24 b is adapted so as topermit the introduction of a sensor, such as, but not limited to, anultrasound or other sensor device for diagnostic imaging within thebody-space tube 10.

In other embodiments in accordance with the present invention, thefilament lumen 37 of the tubular filament 24 b is adapted to introducecameras, or other devices into the body tube lumen 15 while maintaininga sterile environment with respect to body tube 10.

FIG. 12A is a partial side view of an expandable debris-removal system50, wherein the cleaning member 24 is a tubular filament 24 c comprisinga tubular filament distal end 36 b having an expandable portion 44 influid communication with a filament lumen 37, in accordance with anembodiment of the present invention. The expandable portion 44 isadapted to facilitate mechanical manipulation of the foreign material 19to assist in the removal from the body tube lumen 15. The expandableportion 44 is adapted to have a relaxed state in which the tubularfilament distal end 36 has a minimal profile X and an expanded statewherein the tubular filament distal end 36 has an enlarged profile Y.The expandable portion 44 is expanded by the advancement of inflationfluid from an inflation fluid delivery system 45, through the filamentlumen 37 to the expandable portion 44. The inflation fluid is controlledat the tubular member proximal end 38 b.

The expandable portion 44 is adapted to facilitate mechanicalmanipulation of the foreign material 19 to assist in the removal fromthe body tube lumen 15. The expandable portion 44 is advanced distal to(or beyond) the foreign material 19 while in a relaxed state. Theexpandable portion 44 is enlarged to take on a profile to at leastpartially occlude the body tube lumen 15. Withdrawal of the cleaningmember 24 from the body tube lumen 15 causes the expanded portion 44 toabut and dislodge the foreign material 19, carrying the foreign material19 distally to the canister tube 14.

In one embodiment in accordance with the present invention, theexpandable portion 44 is adapted to fully occlude the body tube lumen15, wherein the expandable portion 44 provides a squeegee action toclean the body tube lumen 15 of the foreign material 19.

In embodiments in accordance with the present invention, the fluidpressure of the inflation fluid is delivered to the expandable portion44 by an external fluid source 45 a comprising a reservoir 46 coupled tothe filament lumen 37 at the tubular filament proximal end 38 b of thecleaning member 24. In one embodiment in accordance with the presentinvention, a fluid pressure source 45 a, such as, but not limited to, anelastic bulb or fluid-filled syringe, is provided exterior to thecollapsible sheath 22 and coupled to the cleaning member 24 through acoupling. Sterility of the filament lumen 37 is not essential as thefluid is not in communication with the sterile drainage system 20.

Embodiments of the reservoir 46 comprise, among others, a compliantbulb, balloon, syringe, or other fluid supply means. In one embodimentwherein the reservoir is a compliant bulb, the bulb is compresseddisplacing the fluid from the reservoir 46 expanding the expandableportion 44. The compression of the bulb is subsequently relaxed to allowthe fluid to return to the reservoir 46 and the expandable portion 44 tocollapse to the original state.

FIG. 12B illustrates yet another embodiment in accordance with thepresent invention, wherein the fluid source 45 b, such as, but notlimited to, an elastic bulb, is provided within the collapsible sheath22. In this embodiment, the inflation fluid remains sterile in the eventof rupture of the expandable portion 44.

In the embodiment of FIG. 12A, the expandable portion 44 is a bulb 45 atthe tubular filament distal end 36 b which is adapted to expand underfluid pressure and recoil back to substantially the original positionupon withdrawal of the-fluid pressure. The tubular filament distal end36 b is adapted to expand in a substantially spherical confirmation.Such a configuration can be fabricated in a number of ways, including,but not limited to, preferential material thickness at the tubularfilament distal end 36 b such that the expandable portion 44 expands andthe remaining portion of the tubular filament distal end 36 b remainssubstantially unexpanded. In another embodiment, an expandable portion44, such as a balloon, is coupled to the tubular filament distal end 36b.

FIG. 13 is a side view of another embodiment of the tubular filament 24c in accordance with the present invention, comprising an expandabledistal tip 47 having an arrowhead-shaped or umbrella profile. Such aconfiguration presents an aggressive structure for dislodging and/orbreaking up foreign material 19 when pulled out of the body-space lumen15. Other configurations are anticipated.

FIG. 14 shows an embodiment of the present invention wherein theexpanding portion 44 comprises an expanding wall portion 48 along aportion of the length of the tubular filament distal end 36 b, inaccordance with an embodiment of the present invention. The expandablewall portion 48 is in fluid communication with the filament lumen 37 andadapted so as to expand to an enlarged state Y from a relaxed state Xupon presented with fluid pressure. The expandable wall portion 48 isadapted to expand or contract by the fluid therein. The fluid source issubstantially the same as previously described and shown in FIGS. 12Aand 12B, is adapted to pressurize the filament lumen 37 which in turnexpands the expandable portion 44 to a larger diameter than the relaxedstate. The tubular filament distal end 36 d is advanced such that theexpandable portion 44 extends beyond the foreign material 19 to becleared from the body tube lumen 15. The fluid source is used to inflatethe expandable wall portion 48 to a diameter sufficient so as to permitthe advancement of the foreign material 19 down the body lumen 15 whenthe tubular filament 24 c is pulled in a proximal direction.

In an embodiment in accordance with the present invention, as shown inFIGS. 12A, 13, and 14, the expandable portion 44 is integral with thetubular filament 24 c.

FIG. 15A is a side view of the tubular filament distal end 36 dcomprising an expandable portion 44 not integral with, but coupled to,the tubular filament 24 c, in accordance with an embodiment of thepresent invention. The expandable portion 44 is coupled to the tubularfilament distal end 36 d in manufacturing techniques employed, such as,but not limited to, in the production of angioplasty catheters. In oneembodiment, the expandable portion 45 is a substantially non-resilientfilm material that is adapted to unfold and expand under internal fluidpressure and collapse and refold to a low profile upon the removal ofinternal fluid pressure.

In another embodiment, the expandable portion 44 comprises an elasticmaterial adapted to substantially relax to the original state uponremoval of the internal fluid pressure.

FIG. 15B is a side view of the tubular filament distal end 36 dcomprising a plurality of expandable portions 44, in accordance with anembodiment of the present invention. The plurality of expandableportions 44 are spaced a predetermined distance apart along the lengthof the tubular filament 24 c. Multiple expandable portions 44 provideadditional cleaning surface for abutting, dislodging and moving offoreign material 19.

FIG. 16A is a side view of a tubular filament distal end 36 d comprisingan expandable portion 44, further comprising an elastic cord 56, inaccordance with an embodiment of the present invention. The elastic cord56 is adapted to provide a restoring force to reposition the cleaningmember 24 adjacent the body tube distal end 11. The elastic cord 56 iscoupled to the body tube distal end 11 and the cleaning member distalend 26. As the cleaning member 24 is withdrawn from the body tube 10,the elastic cord 56 presents a return force to bring the cleaning memberdistal end 26 back to the body tube distal end 11.

The elastic cord 56 comprises an elastic property and undergoes tensionas the cleaning member 24 is retracted into the collapsible sheath 22,and, upon release of the cleaning member proximal end 28 of the cleaningmember 24, the cleaning member distal end 26 is drawn towards the bodytube distal end 11.

In the embodiment in accordance with FIG. 16A, the cleaning member 24further comprises a cross-bar support 55 adapted to couple the cleaningmember 24 to the body tube distal end 11. The cleaning member 24 isadvanced to adjacent the body tube distal end 11, wherein the cross-barsupport 55 is slidingly received in the body tube lumen 15 at an acuteangle with the axis of the body tube lumen 15. The cleaning member 24 isadvanced such that the cross-bar support 55 exits the body tube lumen15. The cross-bar support 55 turns substantially perpendicular to thebody tube 10 and acts as an anchor for the elastic cord 56 at the bodytube distal end 11.

FIG. 17 is a side view of a distal end of an umbrella cleaning member 60comprising an umbrella-like expandable portion 58 comprising of aplurality of struts 57 and webs 59, in accordance with an embodiment ofthe present invention. The cleaning member 24 comprises a flexiblefilament having an umbrella-like expandable portion 58 coupled to thefilament distal end 36 e. The umbrella cleaning member 60 is adapted tocollapse to a narrow profile X when advancing beyond the foreignmaterial 19, and expand to substantially occlude the body tube lumen 15when withdrawn, abutting and pushing the foreign material 19 towards thebody tube proximal end 13.

FIG. 18 is a side view of a distal end of a cleaning member comprisingan umbrella-like expandable portion 58 comprising of a plurality ofstruts 57 and webs 59 lifting and moving the foreign material 19distally from the body tube lumen 15. In the expanded state, the webs59, carried by the struts 57, open to at least substantially occlude thebody tube lumen 15 and form an apex 61 pointing distally. The struts 57and the webs 59 provide a structure that is adapted to breakup and/orremove foreign material 19 from the body tube lumen 15 as the cleaningmember 24 is advanced proximally.

In another embodiment in accordance with the present invention,referring again to the embodiment of FIG. 17, the umbrella cleaningmember 60 is coupled to the body tube distal end 11 with a cord 56substantially as described above.

FIG. 19 is a side view of a distal end of a cleaning member 24comprising an umbrella-like expandable portion 58 comprising of aplurality of struts 57 and webs 59 returning (moving distally) to thebody tube distal end 11. The struts 57 and webs 59 fold down to a lowprofile X and substantially parallel with the body tube lumen 15 whenreturning to the body tube distal end 11 and when the cord 56 is in therelaxed state. The undeployed position allows the cleaning member 24 totransit past any remaining foreign material 19 that was not removedsubsequently, as well as allow the continuous flow of drainage fluid.

The umbrella-like expandable portion 58 is adapted to mechanically cleanthe body tube lumen 15 by mechanical dislodgment of the foreign material19. The cleaning member 24 c is sufficiently flexible to traverse thecurvature of the body tube lumen 15, but is sufficiently rigid so as tonot buckle when advanced through the body tube lumen 15 by pushing fromthe proximal end and to advance past the foreign material 19. Further,the umbrella-like expandable portion 58 is sufficiently stiff whenexpanded so as to dislodge the foreign material 19 within the body tubelumen 15 as it makes contact therewith.

FIG. 20 is a side view of a cleaning member distal end 36 e of acleaning member 24 comprises a plurality of umbrella-like expandableportions 58 comprising of a plurality of struts 57 and webs 59, inaccordance with an embodiment of the present invention. The plurality ofumbrella-like expandable portions 58 are coupled to either adjacentumbrella-like expandable portions 58 or to the body tube distal end 11with an elastic cord 56. Having more than one umbrella-like expandableportion 58 reduces the extent in which each umbrella-like expandableportion 58 needs to traverse within the body tube lumen 15. In addition,each cord 56 may elongate independently from each other. It isanticipated that if the umbrella-like expandable portions 58 exhibitsignificant friction against the body tube lumen 15, multiple elasticcords 56 my stretch disproportionate to other elastic cords 56 in amultiple elastic cord system.

The umbrella-like expandable portions 58 are adapted to present afolded/compressed/closed state and an unfolded/extended/open state. Theumbrella-like expandable portions 58 adapted to open when the cleaningmember proximal end 38 is pulled causing the umbrella-like expandableportions 58 to advance towards the body tube proximal end 13, and toclose when the cleaning member proximal end 38 is released causing theumbrella-like expandable portions 58 to be drawn towards the body tubedistal end 11.

FIG. 21 is a side view of a distal end 11 of a body tube that bifurcatesinto a plurality of body tube distal ends 11 a, in accordance with anembodiment of the present invention. The body tube cleaning member 24 ofthe debris-removal system is adapted to be able to traverse any one ofthe multiple body tube distal ends 11 a.

In another embodiment of the present invention, a plurality ofbody-space drainage tubes are received within the body that areinterconnected internal to the body forming a single drainage tubeexiting out of one puncture site, such as, but not limited to,bifurcated or trifurcated tube, permitting the tubes to be kept clearfrom one proximal location, the cleaning member having a plurality ofdistal cleaning members corresponding to the plurality of drainagetubes.

Other embodiments of the present invention include a small diameter bodytube that enters the patient's chest via a small hole. Once inside thechest, the tube divides into two or more ends, herein called phalanges.Within each phalange is a tube clearing device, as described above. Inone application, by way of example, one phalange is positioned over thesurface of the heart, one is positioned along the inferior surface ofthe heart, and one is positioned in the left chest. AU drain to a singletube that exits the body. In this embodiment, all the critical areas ofthe chest are drained through a single tube that exits the chest walland skin.

Likewise, after lung or pleural surgery, one phalange is positionedalong the medial surface of the lung, one along the base along thediaphragm, and one along the posterior gutter going to the apex. In thisway, all the critical areas of the chest are drained after lung surgerywith a single tube exiting the skin and chest wall. Efficacy ismaintained, or even increased, and invasiveness, pain, and ultimatelycosmesis, are all positively addressed. Multiple double-lumen tubes arebonded together using thin, polymeric severable membranes with a singlecommon connector being attached to one end of the tubes.

After the multi-lumen tubes are inserted into the chest cavity through asingle entry in the chest wall, they can be severed to form individualmulti-lumen tubes which can be positioned to drain various sites insidethe chest cavity. The reduction of insertion sites lessens thepossibility of potential chest-tube-site infections. Various embodimentsof the present invention provide a cleaning member that advances in andout of the body tube lumen. Embodiments of the present inventionprovides that body tubes can be miniaturized Clinicians can choosesmaller diameter/lumen body tubes or catheters for drainage if the fearof clotting and clogging is reduced or eliminated. For example, if, forfear of clogging, one routinely uses a 36 F catheter after heartsurgery, with embodiments of the present invention, one could use an 8or 10 F tube, which would hurt less while in place, hurt less whenremoved, and leave a smaller scar. Furthermore, since smaller tubescould be more readily used, they could be more readily inserted by awider base of practitioners, due to the reduced need for expertise toinsert and clinically manage the tube. Smaller holes mean less pain,less risk of infection, and less risk that the patient will have acomplication from air sucking back into the chest through the hole leftin the chest wall while it is healing. Larger holes require a stitch toclose, and stitches need to be removed, which is time-consuming for theclinician and painful and inconvenient for the patient. A 10 F holecould be easily closed with a bandage, rather than requiring a stitch.

What is claimed is:
 1. A debris-removal system comprising: a body tubehaving a body tube proximal end, a body tube distal end, and a body tubelumen having a cross-sectional area; and a cleaning member adapted formanipulation within the body tube lumen, said cleaning member comprisinga flexible wire filament having a flexible filament distal end and acleaning head disposed at or adjacent said distal end of said flexiblewire filament; wherein advancement and/or retraction of said cleaningmember causes a corresponding advancement and/or retraction of saidcleaning head to dislodge debris within said body tube lumen withoutcompromising a sterile field within said body tube, said cleaning memberbeing configured such that the flexible filament distal end cannot exitthe body tube distal end upon advancement of said cleaning member; saidcleaning head being configured such that it permits free flow ofmaterial past and around the cleaning head across the cross-sectionalarea of the body tube lumen while the cleaning head is being used todislodge debris.
 2. The debris-removal system of claim 1, said cleaninghead being disposed at the flexible filament distal end.
 3. Thedebris-removal system of claim 1, further comprising a suction drawn insaid body tube lumen from the body tube proximal end, wherein debrisdislodged from said interior wall surface by said cleaning head is drawnthrough said body tube lumen and out the body tube proximal end via saidsuction.
 4. The debris-removal system of claim 1, said cleaning headhaving a straight cross-section.
 5. The debris-removal system of claim4, said cross-section being obliquely angled with respect to alongitudinal axis of the flexible filament.
 6. The debris-removal systemof claim 1, further comprising a collapsible sheath in communicationwith said body tube lumen, said collapsible sheath being adapted tocontain at least a portion of the cleaning member that is not containedwithin the body tube lumen, wherein compromising said sterile field onadvancement and/or retraction of said cleaning member is avoided byexternal digital manipulation of the cleaning member, through saidcollapsible sheath, to advance and/or retract the same in said body tubelumen.
 7. The debris-removal system of claim 6, said collapsible sheathbeing provided in communication with a distal end of said body tubelumen via a coupler.
 8. The debris-removal system of claim 1, saidcleaning member being disposed within said body tube lumen.
 9. Thedebris-removal system of claim 1, said flexible filament beingsufficiently flexible to traverse a curvature of said body tube lumen.10. The debris-removal system of claim 1, said body tube lumen beingunder a vacuum drawn from the body tube proximal end.
 11. The debrisremoval system of claim 1, said cleaning head comprising a distal tip ofsaid flexible filament.
 12. A debris-removal system comprising: a bodytube having a body tube proximal end, a body tube distal end, and a bodytube lumen having a cross-sectional area; and a cleaning member disposedand adapted for manipulation within the body tube lumen, said cleaningmember comprising a flexible wire filament having a flexible filamentdistal end that consists essentially of a tip having a cross-sectionthat is at an angle with respect to a longitudinal axis of said flexiblewire filament, said tip being engaged with an interior wall surface ofsaid body tube; wherein advancement and/or retraction of said cleaningmember causes a corresponding advancement and/or retraction of said tipagainst said interior wall surface to dislodge debris adhered theretowithout compromising a sterile field within said body tube, saidcleaning member being configured such that said tip cannot exit the bodytube distal end upon advancement of said cleaning member; said tip beingconfigured such that it permits free flow of material past and aroundthe tip across the cross-sectional area of the body tube lumen while thecleaning head is being used to dislodge debris.
 13. The debris-removalsystem of claim 12, further comprising a suction drawn in said body tubelumen from the body tube proximal end, wherein debris dislodged fromsaid interior wall surface by said tip is drawn through said body tubelumen and out the body tube proximal end via said suction.
 14. Thedebris-removal system of claim 12, said tip having a straightcross-section.
 15. The debris-removal system of claim 14, saidcross-section being obliquely angled with respect to a longitudinal axisof the flexible filament.
 16. The debris-removal system of claim 12,further comprising a collapsible sheath in communication with said bodytube lumen, said collapsible sheath being adapted to contain at least aportion of the cleaning member that is not contained within the bodytube lumen, wherein compromising said sterile field on advancementand/or retraction of said cleaning member is avoided by external digitalmanipulation of the cleaning member, through said collapsible sheath, toadvance and/or retract the same in said body tube lumen.
 17. Adebris-removal system comprising: a branched body tube comprising aproximal tube having a proximal lumen and a plurality of distal tubeshaving respective distal lumens, each distal lumen being in fluidcommunication with said proximal lumen; and a cleaning member adaptedfor manipulation within each distal lumen, said cleaning membercomprising a flexible filament having a flexible filament distal end anda cleaning head disposed at or adjacent said distal end of said flexiblefilament; wherein advancement and/or retraction of said cleaning membercauses a corresponding advancement and/or retraction of said cleaninghead effective to dislodge debris within said branched body tube. 18.The debris removal system of claim 17, said distal tubes branching fromsaid proximal tube at a common location.
 19. The debris removal systemof claim 17, said cleaning member being operable to advance saidcleaning head into any of said distal lumens to dislodge debris therein.20. The debris removal system of claim 17, comprising only one cleaningmember.
 21. The debris removal system of claim 17, said cleaning headbeing configured such that it permits free flow of material past thecleaning head through a lumen of said body tube regardless whether thecleaning head is at rest within said lumen or is being advanced and/orretracted therein to dislodge debris.
 22. The debris removal system ofclaim 17, said system being configured such that the flexible filamentdistal end cannot exit the body tube upon advancement of said cleaningmember.
 23. The debris removal system of claim 17, comprising aplurality of cleaning members, each said distal lumen having anassociated one of said cleaning members to dislodge debris therefrom.